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Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-intensity laser therapy (HILT)
Sham laser
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring High-intensity, pain, knee osteoarthritis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with primary knee OA diagnosed based on the American college of rheumatology (ACR) guidelines for early diagnosis of knee osteoarthritis 2016.
  • Patients who had knee pain for at least 6 months and had VAS score greater than 4 out of 10 points
  • Patients with knee OA who have Kellgren And Lawrence (KL) classification stages 2-4.

Exclusion Criteria:

  • Patients who have secondary knee OA caused by other pathologies
  • Patients who have a history of corticosteroid or hyaluronate injecting into the knee joint within the past 6 months
  • Patients who were treated by physical therapy equipment within 1 month before the study
  • History of stroke, bleeding disorders, cancer, deep vein thrombosis, cognitive impairment, or mental disorders
  • Contraindicate to laser therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    High-intensity laser therapy (HILT)

    Sham laser

    Arm Description

    The participants in the intervention group were treated by HILT which was applied to the knee joint (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.

    The control group received a sham laser by the same laser machine (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale (VAS)
    VAS is the standardized pain measurement which allows subjects to rate pain score by using the ruler scale. This pain scale starts from 0 which means no pain to 10 which means maximum pain.

    Secondary Outcome Measures

    Thai version of the Western Ontario and McMaster (WOMAC) Osteoarthritis Index for knee osteoarthritis (T-WOMAC)
    WOMAC score is the questionnaire used to assess pain and function in patients with knee OA. This score consists of 3 subscale including pain, function and joint stiffness. The total scores of all subscales are 96 points in which the higher score reflects the more disabled of the patient. For Thai version of WOMAC, this score has been proven valid for using in patients with knee OA.

    Full Information

    First Posted
    May 7, 2021
    Last Updated
    May 12, 2021
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04889885
    Brief Title
    Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis
    Official Title
    Short Term Efficacy of High-intensity Laser Therapy to Alleviate Pain in Patients With Knee Osteoarthritis: a Double-blinded Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    August 31, 2016 (Actual)
    Study Completion Date
    August 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Knee osteoarthritis (KOA) is one of the most common health problems around the world. According to this, several interventions have been used to treat this group of patients including pharmacological and non-pharmacological management such as weight reduction, behavior modification, and physical therapy. Recently, high-intensity laser therapy (HILT) has been used to treat patients with KOA. The results of previous studies showed that HILT could help to reduce pain as well as improved function in patients with mild to moderate KOA. However, there were still no standardized guidelines for HILT treatment in KOA. Also, no previous studies evaluated the efficacy of HILT in patients with severe KOA. The present study, therefore, recruited not only mild to a moderate degree but also severe degree. The study aim was to determine the efficacy of HILT in terms of pain relief in patients with mild, moderate, and severe KOA. The hypothesis was HILT would effectively reduce pain in patients with KOA compared to sham laser plus conservative treatment.
    Detailed Description
    This study is a double-blinded randomized control trial that compared the efficacy of HPLT to sham laser in patients with KOA. 42 patients who had KOA diagnosed by the American college of rheumatology (ACR) 2016 guidelines were recruited including a drop out of 20%. The participants were then randomly allocated into two groups (21 participants per group), mainly HILT and sham laser. Also, both groups received conservative treatment such as disease education, exercise, and advice for weight reduction. The intervention group received HILT which was applied on the medial, lateral, and posterior part of the knee joint. The total energy was 562.5 J per session which was done 2-3 sessions a week, for a total of 10 sessions. The control group received sham laser by the same device for 10 sessions plus conservative treatment as in the intervention group. The outcome measures, VAS and T-WOMAC score were recorded before and at the end of the study. Statistical analysis was performed using SPSS 18.0 version to evaluate the statistically significant change within the same group and the difference between groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    High-intensity, pain, knee osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High-intensity laser therapy (HILT)
    Arm Type
    Experimental
    Arm Description
    The participants in the intervention group were treated by HILT which was applied to the knee joint (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.
    Arm Title
    Sham laser
    Arm Type
    Sham Comparator
    Arm Description
    The control group received a sham laser by the same laser machine (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.
    Intervention Type
    Device
    Intervention Name(s)
    High-intensity laser therapy (HILT)
    Other Intervention Name(s)
    High-power laser therapy (HPLT)
    Intervention Description
    HILT was done by Multiwave Locked System (MLS) laser therapy combining 2 laser wavelengths (808 and 905 nm) in order to strengthen the effects of HILT. The laser was applied on medial, lateral and posterior parts around the knee joint. The total energy per session was 562.5 Joules (J) which was done 2-3 times a week for a total of 10 sessions. Additionally, the participants received conservative treatment for knee OA such as education about the disease, proper activities, and exercise.
    Intervention Type
    Device
    Intervention Name(s)
    Sham laser
    Intervention Description
    The control group received a sham laser (2-3 times a week for a total of 10 sessions) plus conservative treatment as in the intervention group. The laser machine was the same as in the intervention group; however, the laser was applied without releasing laser energy to the knee joint.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS)
    Description
    VAS is the standardized pain measurement which allows subjects to rate pain score by using the ruler scale. This pain scale starts from 0 which means no pain to 10 which means maximum pain.
    Time Frame
    VAS was recorded in the two time points. The first time point was at the baseline or before starting the treatment. After that, VAS was recorded post-intervention (at 4 weeks from baseline) as the second time point.
    Secondary Outcome Measure Information:
    Title
    Thai version of the Western Ontario and McMaster (WOMAC) Osteoarthritis Index for knee osteoarthritis (T-WOMAC)
    Description
    WOMAC score is the questionnaire used to assess pain and function in patients with knee OA. This score consists of 3 subscale including pain, function and joint stiffness. The total scores of all subscales are 96 points in which the higher score reflects the more disabled of the patient. For Thai version of WOMAC, this score has been proven valid for using in patients with knee OA.
    Time Frame
    T-WOMAC was recorded in the two time points. First, T-WOMAC was recorded at the baseline and was then recorded post-intervention (at 4 weeks from baseline) as the second time point.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with primary knee OA diagnosed based on the American college of rheumatology (ACR) guidelines for early diagnosis of knee osteoarthritis 2016. Patients who had knee pain for at least 6 months and had VAS score greater than 4 out of 10 points Patients with knee OA who have Kellgren And Lawrence (KL) classification stages 2-4. Exclusion Criteria: Patients who have secondary knee OA caused by other pathologies Patients who have a history of corticosteroid or hyaluronate injecting into the knee joint within the past 6 months Patients who were treated by physical therapy equipment within 1 month before the study History of stroke, bleeding disorders, cancer, deep vein thrombosis, cognitive impairment, or mental disorders Contraindicate to laser therapy

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36313402
    Citation
    Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.
    Results Reference
    derived

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    Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis

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